Fasedienol (PH94B) - (PALISADE-2)

Aug. 6, 2026: Vistagen (NASDAQ: VTGN) reported topline results from an exploratory Phase 2 repeat-dose study of fasedienol nasal spray for acute treatment of social anxiety disorder in adults undergoing a public speaking challenge. The randomized, double-blind, placebo-controlled three-arm trial (N=61) compared two 3.2 µg doses given 10 minutes apart, a single 3.2 µg dose, and placebo; it was not powered for statistical significance.

The study met its safety objective: repeat dosing showed safety/tolerability comparable to single-dose treatment, with no new safety findings. On the primary endpoint, change in SUDS score from baseline speech to randomized speech, active arms numerically outperformed placebo but were not statistically significant: pooled fasedienol -15.0 (p=0.10), repeat dose -15.4 (p=0.17), single dose -14.7 (p=0.14), vs placebo -6.8.

In a prespecified very severe subgroup (baseline LSAS ≥95), pooled fasedienol and single-dose fasedienol showed nominally significant improvement vs placebo: -16.2 (p=0.04) and -15.3 (p=0.05), vs placebo -1.6. Secondary CGI-I and PGI-C responder rates were directionally higher for fasedienol than placebo, and an exploratory anticipatory anxiety analysis showed nominal significance for pooled fasedienol (p=0.03) and repeat dose (p=0.01). Vistagen said the data will support FDA discussions on a potential registrational pathway; fasedienol remains in U.S. Phase 3 development.